510(k) · Cleared
Recalled · Class II · 2024Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Corp. · HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Cleared on Apr 23, 2015 as substantially equivalent to K112593 (Stryker Corporation, 2012) and 1 other predicate after a 155-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it. It has been recalled 7 times.
- Decided
- Apr 23, 2015
- Review
- 155 days
- Class
- Class II
- Product code
- HBE
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 2 generations to K020069 (2002). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK020069 Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High…Medtronic Midas Rex · 2002 · Recalled
- 1 generation backK041754 Stryker Maestro SystemStryker Corp. · 2004
- This deviceK143320 Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp. · 2015
- Descendant · cites it directly · 5 of its ownK190172 Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker · 2019
- Descendant · 2 generations on · 4 of its ownK241171 Spine Guidance Software (Version 5.1); Consolidated Operating Room…Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 3 generations on · 2 of its ownK241517 Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024
- Descendant · 3 generations on · 1 of its ownK252871 Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q…Stryker Leibinger GmbH & Co KG · 2026
- Descendant · 4 generations on · 0 of its ownK253623 Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine…Stryker Leibinger GmbH & Co KG · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker · 2019 · cites it directly5descendants
- K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG · 2024 · 2 generations on4descendants
- K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG · 2024 · 3 generations on2descendants
- K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting…Stryker Leibinger GmbH & Co KG · 2026 · 3 generations on1descendant
- K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020069 | Medtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System… | Medtronic Midas Rex | 2002 | 9 |
| −1 | K041754 | Stryker Maestro System | Stryker Corp. | 2004 | — |
| 0 (this device) | K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker Corp. | 2015 | — |
| +1 | K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | Stryker | 2019 | — |
| +2 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment… | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +3 | K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024 | — |
| +3 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments… | Stryker Leibinger GmbH & Co KG | 2026 | — |
| +4 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4… | Stryker Leibinger GmbH & Co KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HBE device
- #1 K251433 Surgify Halo (54.085.SHD.H1); Surgify Halo…score 13.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K112593 | Styker Consolidated Operating Room Equipment (Core) SystemSummary page 4…imary Predicate ERL (primary) Stryker® Consolidated Stryker K112593 DZI, DZJ, HBE Operating Room Equipment… | 2012 |
| * | K041754 | Stryker Maestro SystemSummary page 4…) (CORE) System Secondary Predicate HBB (primary) Stryker Maestro Pneumatic Stryker K041754 ERL, HBE System Instruments… | 2004 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190172 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments | 2019 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2024 | Class II | Z-0063-2025 | Process control | May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be… |
| Jun 28, 2023 | Class II | Z-0980-2025 | Process control | There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device). |
| Jun 28, 2023 | Class II | Z-0981-2025 | Process control | There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa). |
| Jun 28, 2023 | Class II | Z-0982-2025 | Process control | There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa). |
| Jun 24, 2022 | Class II | Z-1478-2022 | Process change control | There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to… |
| Jun 16, 2016 | Class II | Z-2205-2016 | Under Investigation by firm | Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating… |
| Jun 16, 2016 | Class II | Z-2204-2016 | Under Investigation by firm | Stryker Instruments initiated a voluntary recall of specific lots of Round Fluted Burs, due to tarnishing or corrosion which may be present on the recalled burs and could result in a foreign body reaction (inflammation) necessitating… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 10.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K190172 (Stryker, 2019) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K112593.
How does its category compare?
All HBE devicesHBE Drills, Burrs, Trephines & Accessories (Simple, Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HBE
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBE
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HBE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBE
1,924in 2025
MAUDE reports naming product code HBE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 14 |
| 2008 | 2 | — | 47 | 14 |
| 2009 | 0 | — | 7 | 242 |
| 2010 | 0 | — | 23 | 492 |
| 2011 | 2 | — | 1 | 1,013 |
| 2012 | 1 | — | 26 | 1,146 |
| 2013 | 1 | — | 4 | 1,583 |
| 2014 | 2 | — | 0 | 559 |
| 2015 | 3 | 155 | 0 | 483 |
| 2016 | 2 | — | 7 | 848 |
| 2017 | 2 | — | 3 | 848 |
| 2018 | 2 | — | 0 | 787 |
| 2019 | 5 | 133 | 0 | 836 |
| 2020 | 0 | — | 0 | 1,025 |
| 2021 | 6 | 193 | 1 | 1,047 |
| 2022 | 2 | — | 0 | 900 |
| 2023 | 2 | — | 3 | 948 |
| 2024 | 0 | — | 1 | 1,153 |
| 2025 | 6 | 30 | 0 | 1,924 |
| 2026 | 1 | — | 19 | — |
What is it indicated for?
The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat…
Read the full statement (187 words)
The Elite and Heavy Duty Attachments are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE) console and electric and pneumatic motors. When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut bone and bone cement in the following manner: drilling, reaming, decorticating, shaping, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose and Throat (ENT)/Otology/Neurotology/Otorhinolaryngology; Craniofacial and Maxillofacial; Dental; and Endoscopic applications.
The specific applications include Craniotomy/Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/Anterior Skull Base/Endoscopic/Transnasal/Transphenoidal, and Orthopedic Spine.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are intended to cut teeth in the following manner: sectioning, segmenting, splitting, fragmenting, extracting, removing, drilling, and reaming.
When used with these motors, the Elite and Heavy Duty Attachments and Cutting Accessories are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices, or the cutting of screws, metal, wires, pins, and other fixation devices in the following manner: sectioning, deburring, smoothing or shaping of metal, and removing/rounding sharp edges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143320: Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143320
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026